Phase II Trial of Fruquintinib With Sintilimab in Treating Selected Refractory Metastatic Colorectal Cancer Patients
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
This is a prospective, Single arm Phase II trial. Patients were eligible to participate when
they had histological or cytological confirmed metastatic colorectal adenocarcinoma
Non-MSI(microsatellite instability)-high and TMB(tumor mutational burden)-High.
Patients had to have received at least a second-line standard therapy, including
fluoropyrimidine, oxaliplatin, or irinotecan-based regimens and VEGF(vascular endothelial
growth factor) inhibitors and to have disease progression within 3 months after the last
administration of the last standard therapy or to have stopped such therapy due to
unacceptable toxicities. Pre-treatment with anti-EGFR(epidermal growth factor receptor) were
mandatory if RAS(Rat sarcoma virus) wild and left side .
Patients who met the eligibility criteria took fruquintinib plus Sintilimab until disease
progression, death, unacceptable toxicity, withdrawal of consent by the patient, or decision
by the treating physician that discontinuation would be in the patient's best interest. The
primary study endpoint was PFS(progression free survival) rate at 6 months.